510(k) K254191 · FRO Dressing, Wound, Drug
IWD-Gel
| Applicant | InnovaCorium, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Apr 7, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254191
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.